Prefilled syringe jet injector

ABSTRACT

A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of currently pending U.S. patentapplication Ser. No. 13/758,907, filed Feb. 4, 2013, which is acontinuation of U.S. patent application Ser. No. 13/236,120, filed Sep.19, 2011, and patented as U.S. Pat. No. 8,562,564 on Oct. 22, 2013,which is a continuation of U.S. patent application Ser. No. 11/781,832,filed Jul. 23, 2007, and patented as U.S. Pat. No. 8,021,335 on Sep. 20,2011, which is a continuation of expired International Application No.PCT/US2006/002429, filed Jan. 24, 2006, which claims the benefit ofexpired U.S. Provisional Application Nos. 60/645,590, filed Jan. 24,2005, and 60/709,116, filed Aug. 18, 2005, the content of each of whichis expressly incorporated herein by reference thereto.

FIELD OF THE INVENTION

The present invention relates to a jet injector, and more particularlyto a needle-assisted jet injector that uses a low jet injectionpressure.

BACKGROUND OF THE PRESENT INVENTION

Examples of needle-free injectors are described in U.S. Pat. Nos.5,599,302; 5,062,830; and 4,790,824. These traditional injectorsadminister medication as a fine, high velocity jet delivered undersufficient pressure to enable the jet to pass through the skin. Thepressure used to deliver the medication is typically greater thanapproximately 4000 p.s.i. inside the compartment that contains themedicament in the injector. Benefits derived from such pressures, inaddition to allowing injection without needles, include the speed of theinjection, the dispersion of the injected medicament in the tissue andinjection delivery without impact from the resistance by the tissuewhere the medicament is delivered.

Self-injectors or autoinjectors like the ones disclosed in U.S. Pat.Nos. 4,553,962 and 4,378,015 and PCT Publications WO 95/29720 and WO97/14455 are constructed to inject medicament at a rate and in a mannersimilar to hand-operated hypodermic syringes. The self-injectors orautoinjectors have needles that are extended at the time of activationto penetrate the user's skin to deliver medicament through movement ofthe drug container and related needle. Thus the mechanism that providesthe force to deliver the medicament in self-injectors and autoinjectorsis also used to extend the needle and the drug container to cause theinsertion of the needle through the user's skin. The autoinjectorsmanufactured, for example by Owen Mumford, thus use very low pressuresto inject the medicament, which is injected through a needle in arelatively slow stream. The pressures applied in themedicament-containing compartments of this type of device are very low,reaching a maximum of around 60 p.s.i. and take around 6 seconds toinject 1 mL. These devices do not deliver of the medicament using jetinjection, so the medicament is delivered in a bolus at the tip theneedle, which typically penetrates the patient by typically at leastabout 12 mm. When these low pressures and injection rates are used withshorter needles, especially those that penetrate the patient around 5 mmor less, there is a high incidence of leakback of the injectedmedicament around the needle or through the hole in the tissue created.

Prefilled syringes, such as those presently sold by Becton and Dickinsonas the BD Hypak™ are intended for slow speed, manual or autoinjectorinjections. While prefilled syringes are readily available, themanufacturing techniques employed result in dimensional tolerances thattraditionally have been considered too loose for jet injectors since thesyringe would need to withstand a very sharp application of an elevatedpressures sufficient to jet inject the medicament. Additionally,prefilled syringes include portions shaped to hold the needle andflanges for grasping for injection by hand that result in features thatcan be susceptible to breakage. Residual stresses that are present inthe syringe bodies also increase their fragility, which is one of thereasons they have typically been considered too fragile for use in a jetinjector. Thus, jet injectors have typically used more robust cartridgeswithout features intended for handheld use, and which are manufacturedwith tighter tolerances than typical prefilled syringes.

An injector is needed that can reliable inject medicament to a desiredsite without a substantial risk of the medicament leaking back out fromthe patient's skin, at a fast speed substantially without regard totissue resistance, and preferably being able to use a standard prefilledsyringe.

SUMMARY OF THE INVENTION

The invention is related to a jet injector. The preferred embodimentemploys a prefilled syringe that is preferably prefilled with amedicament prior to the assembly of the device. The syringe has acontainer portion that defines a fluid chamber containing a medicament.An injection-assisting needle is disposed at the distal end of thechamber and has an injecting tip configured for piercing an insertionlocation. The needle defines a fluid pathway in fluid communication withthe chamber for injecting the fluid from the chamber into an injectionsite. The syringe also has a plunger that is movable within the fluidchamber.

In this embodiment, a housing houses the prefilled syringe and isconfigured for allowing insertion of the needle at the injectionlocation to an insertion point that is at a penetration depth below thesurface at the insertion location. A syringe support supportively mountsthe prefilled syringe to the housing, and an energy source is configuredto bias the plunger with a force selected to produce an injectingpressure in the medicament in the fluid chamber of between about 80 and1000 p.s.i. This pressure injects the medicament from the fluid chamberthrough the needle to an injection site that is remote from theinjecting tip. The penetration depth and injecting pressure arepreferably sufficient to permit better medicament distribution than inautoinjectors and to substantially prevent backflow of the injectedmedicament. In the preferred embodiment, the injection rate issubstantially unaffected by tissue resistance.

The energy source, which preferably comprises a spring, is preferablyconfigured to produce the injecting pressure that remains below about500 p.s.i. and above about 90 p.s.i. during the injection of themedicament. More preferably, the injecting pressure remains at least atabout 100 p.s.i. and up to about 350 p.s.i. during the injection of themedicament.

The preferred housing is configured for allowing insertion of a portionof the needle to the penetration depth of between about 0.5 mm and 5 mmbelow the surface at the insertion location. In one embodiment, thepenetration depth is between about 1 mm and 4 mm, and more preferably isless than about 3 mm. The injecting pressure and penetration depth insome embodiments preferably are sufficient such that the injection siteis subcutaneous, although other types of injection can be achieved inother embodiments. For intramuscular injections, for example, theexposed portion of the needle can be around 10 mm to 15 mm, for example,with a preferred embodiment being around 13 mm.

The syringe has a distal portion of the prefilled syringe, in which theinjection-assisting needle is located, and a proximal portion oppositethe distal portion. The syringe support can be configured to axialsupport the proximal portion of the pre-filled syringe during the jetinjection of the medicament, such that the distal portion of theprefilled syringe is substantially unsupported in an axial direction.

The prefilled syringe is preferably made of blown glass, which can beformed on the injection-assisting needle, but is usually formed andadhered to the needle. Additionally, the preferred volume of the fluidchamber is about between 0.02 mL and 4 mL of the medicament.

The housing of the preferred embodiment comprises a retractable guardthat is movable between a protecting position and an injecting position.In the protecting position, the needle is disposed within the guard, butin the injecting position, the tip of the needle is exposed forinsertion to the insertion point. A trigger mechanism can be operablyassociated with the energy source for activating the energy source tojet inject the medicament. The trigger mechanism is preferablyconfigured for activating the energy source after the retractable guardis retracted from the protecting position, and most preferably once itis retracted to the injecting position.

A syringe cushion can be provided in association with the syringesupport and the prefilled syringe to compensate for shape irregularitiesof the pre-filled syringe and/or to cushion and provide shock absorptionto the syringe during the device firing. In one embodiment, a ram thatis biased by the spring against the plunger to produce the injectingpressure is provided with a bell portion on which the spring of theenergy source is seated. The bell portion defines a hollow interiorconfigured for receiving the prefilled syringe when the device is fired,such that the spring surrounds the prefilled syringe.

The present invention thus provides a jet injection device that offersbetter medicament distribution and can reliably use a shorter needlethat low pressure, non-jet injectors. Also, the inventive jet injectorcan benefit from simplified manufacturing by using a prefilled syringe,which traditionally is used for slow injections.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a preferred embodiment of a jet injectorconstructed according to the present invention, showing the injectorprior to injection;

FIG. 2 is a cross-sectional view thereof taken along plane II-II;

FIG. 3 is a perspective view of a prefilled syringe for use in thepreferred embodiment

FIG. 4 is a perspective view of a syringe cushion of the preferredembodiment;

FIG. 5 is a cross-sectional view of embodiment of FIG. 1, showing theinjector at the start of the jet injection of the embodiment containedtherein;

FIG. 6 is a graph showing the typical pressure present in the pollutedchamber that contains medicament in the preferred embodiments during jetinjection;

FIG. 7 is a side view of another embodiment of an injector that isconfigured for using a narrow diameter prefilled syringe;

FIG. 8 is a cross-sectional view thereof; taken on VIII-VIII; and

FIG. 9 is a cross-sectional view of another embodiment of an injectorusing a needle for intramuscular jet-injection.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1 and 2, a preferred embodiment of an injector 10 hasa housing 12 configured for allowing a user to handle the injector 10.The housing 12 includes an outer housing member 14 that substantiallyhouses most of the components shown in FIG. 2. A syringe support member16 is housed within and mounted with the housing 12. The syringe supportmember 16 is configured to hold and position a prefilled syringe 18,which is shown in FIG. 3. In the preferred embodiment, the syringesupport member 16 is substantially fixed to the housing 12, such as bysnaps, an adhesive, a weld, or another known attachment. The prefilledsyringe 18 has a container portion 20 that defines in its interior afluid chamber 22, which is prefilled with medicament to be injected. Atthe distal end of the prefilled syringe 18 is an injection-assistingneedle 24. Needle 24 has an injecting tip 26 configured as known in theart to penetrate the tissue of a patient, preferably the skin. A needlebore extends through the needle 24, as known of the art. The bore is influid communication with the medicament in the fluid chamber 22 and isopen at the needle tip 26 to inject the medicament.

At a proximal side of the fluid chamber 22, opposite from the needle 24,is a plunger 28 that seals the medicament in the fluid chamber 22. Asyringe wall 30 preferably comprises a tubular portion, preferablyclosed at a distal end and open at a proximal end, to define the fluidchamber 22. Plunger 28 is slideably received in the tubular portion. Theprefilled syringe 20 is configured such that when the plunger 28 isdisplaced in a distal direction, the volume of the fluid chamber 22 isdecreased, forcing the medicament out therefrom and through the bore ofneedle 24.

At the distal end of the fluid chamber 22 is a needle hub portion 32 towhich the needle is mounted. A syringe flange 34 extends radially,preferably from the proximal end of the syringe wall 30.

In the preferred embodiment, the syringe 18 has a syringe body 36 thatincludes the flange 34 wall 30 and hub portion 32 is of unitaryconstruction. A preferred material for the syringe body 36 is glass, butother materials can be used in other embodiments. A suitable prefilledsyringe is the BD Hypak™, which is available in various sizes andvolumes and is sold prefilled with medicament. The glass of the syringebody is adhered to the needle. Typical medicaments and medicamentcategories include epinephrine, atropine, sumatriptan, antibiotics,antidepressants, and anticoagulants. Using a prefilled syringefacilitates handling of the medicament when the injector is assembled,and there is an extensive body of knowledge of how the medicaments keepand behave in a prefilled syringe.

A syringe cushion 38, which is shown in detail in FIG. 4, is preferablymade of an elastomeric material or other resilient material. A flange 40of the syringe cushion 38 extends radially and is disposed and serves asan interface between the distal side of the syringe support member 16and the syringe flange 34. Elevated portions, such as nubs 42 extendproximately from the cushion flange 40 and are configured anddimensioned to abut the syringe flange 34.

Prefilled syringes that are manufactured by a blown glass process canhave significant dimensional tolerances and unevenness, particularly inthe glass body 36. The cushion 38 can serve to accommodate the shapeirregularities and to properly position and locate the prefilled syringe18 within the syringe support 16. Typically, the axial thickness ofglass blown syringe flanges on a 1 mL prefilled syringe is within about+0.5 mm. For a BD Hypak™ 1 mL standard prefilled syringe, the thicknessof the syringe flange 34 is 2 mm +0.5 mm or −0.4 mm, and in a 1 mL longconfiguration BD Hypak™ syringe, the flange axial thickness is about1.65 mm±0.25 mm. Other dimensional variations that occur in typicalglass prefilled syringes are in the internal and external diameters ofthe tubular wall 30. These variations can be accommodated by theresilient sleeve portion 44 of the syringe cushion 38, which extendsaxially around the interior of the syringe support 16. The syringecushion 38 is preferably received in the interior of the syringe supportmember and receives the syringe body 36, preferably fitting snuglytherein.

The sleeve portion 44 preferably has radially inwardly extendingprotrusions 46 with a surface area and configuration selected to allowthe insertion of the prefilled syringe 18 therein during assembly, butproviding sufficient friction to maintain the syringe 18 in place and toprovide cushioning and shock absorption during the firing of theinjector. Outward protrusions 48 are also provided on the sleeve portion44, which can be received in corresponding recesses of the syringesupport 16 to prevent axial rotation therebetween. Recessed areas 50 canbe provided on the interior and exterior of the syringe cushion 38opposite corresponding protrusions 48 on the opposite radial side of thesleeve portion 44 if an increased wall thickness of the sleeve portion44 is not desired. In an alternative embodiment one or both of theflange 40 and sleeve 44 of the syringe cushion 38 are substantiallysmooth, substantially without any protrusions. Preferably, the materialand configuration of the syringe cushion 38 is also sufficient toentirely support the prefilled syringe 20 to withstand a firing forceapplied axially in a distal direction on the plunger 28. Thus, theentire support for the prefilled 20 can be provided on the syringeflange 34, while the distal end of the syringe 18 may itself besubstantially unsupported in an axial direction. This can help withstandthe shock on the glass body 36 of the prefilled syringe 20 produced bythe elevated pressures within the fluid chamber 22.

To radially position the distal end of the prefilled syringe 18, thesyringe support 16 preferably has a narrowed bore portion 51 that ispreferably configured to abut the outside of the syringe wall 30. Thisis especially beneficial when the needle is inserted into the patient'sskin. The narrowed bore portion can be made of a resilient material,such as an elastomer, or it can be made unitarily with the rest of thesyringe support 16, preferably of a plastic material.

A trigger mechanism 52 is preferably also housed within housing 12. Thetrigger mechanism 52 includes an inner housing 54 that can be attachedto the outer housing 14, such as by snaps, an adhesive, a weld, or otherknown attachment. Trigger protrusions 56 extend inwardly from theproximal end of the inner housing 54 and are resiliently biasedoutwardly. Trigger protrusions 56 are received in a recess 58 of ram 60in blocking association therewith to prevent distal movement of the ram60 prior to the firing of the device. The ram 60 is urged towards thedistal end of the injector 10 by an energy source, which preferably is acompression spring 52, although other suitable energy sources canalternative be used such as elastomer or compressed-gas springs. Apreferred type of compression spring is a coil spring.

A trigger member of the trigger mechanism 52, such as a latch housing64, is provided exterior to the inner housing to retain the triggerprotrusions 56 in the blocking association in the recess 58 to preventpremature firing of the injector 10. The latch housing 64 is slideableinside the outer housing 14 with respect to the inner housing 54,preferably in an axial direction, and the latch housing 64 preferablysurrounds the inner housing 54.

The housing 12 has a needle guard 66 that is moveable with respect tothe outer housing 14. The needle guard 66 is shown in FIGS. 1 and 2 in aprotecting position, in which the needle 24 is disposed within the guard66. The needle guard 66 is retractable, preferably into the out housing14, in a proximal direction to an injecting position, in which theneedle tip 26 and an end portion of the needle 24 is exposed as shown inFIG. 5 for insertion into a patient. In the preferred embodiment, theproximal movement of the guard is prevented substantially at theinjecting position.

The needle guard 66 is associated with the latch housing 64 such thatwhen the guard 66 is displaced distally it slides the latch housing 64also in a distal direction to release the trigger protrusions 56 fromthe recess 58. Preferably, the latch housing 64 has a latching portion68 that abuts the inner housing 54 in an association to bias andmaintain the trigger protrusions 58 positioned in the blockingassociation with the ram 60 prior to the firing of the device 10. Whenthe latch is slid proximately by the retracting of the guard 66 to theinjecting position, the latching portion 68 slides beyond the portion ofinner housing 54 that is contacts to flex the trigger protrusions 56into the recess 58 of the ram 60, allowing the trigger protrusions 56 tomove radially outwardly from the recess 58 and therefore from theblocking association. When this happens, spring 62 biases the ram 60against plunger 28 to fire the jet injector. Latch housing 64 preferablydefines trigger openings 70 adjacent to latching portions 68, which isconfigured to receive a portion of the inner housing 54, such as thesurface disposed radially outwardly from the trigger protrusions 56.

The guard 66 is preferably resiliently biased distally towards theprotecting position by compression coil spring 72. Also, the needleguard 66 has an axial opening 74 to allow the needle 24 pass therethrough, and which may be sized according to the type of injectordesired. The construction of the present embodiment allows a user topush the distal end of the injector 10 against the patient's skin,pushing the needle 24 into the skin at an insertion location,substantially at the same speed as the injector is pushed. Once theneedle 24 is fully inserted to an insertion point at a penetrationdepth, the trigger mechanism 56 fires the jet injection to an injectionsite.

Preferably, the prefilled syringe 18 and its needle 24 are not shuttledforward automatically into the patient's skin, such as by the firingenergy source during the injection firing. The user preferably gentlypushes the entire device forward to insert the needle, preferablyretracting a guard against the skin in the process. The prefilledsyringe 18 preferably remains is a substantially stationary within thehousing 12, and is preferably substantially fixed thereto. In thismanner, the present invention provides for a gentler treatment of thesyringe during injection that enables the use of a sufficiently powerfulspring 62 or other energy source to produce a jet injection without therisk of damaging the relatively fragile and complex shapes of theprefilled syringe, also allowing, for example, the injection of highviscosity solutions, where the risk of breaking a syringe, such as atthe flange, is elevated in prior art injectors that shuttle the syringeforward in the housing and into the patient. Residual stresses are alsooften present in the glass bodies of prefilled syringes, and thisconfiguration reduces the additional stresses imposed thereon duringuse, further protecting the syringe. Also, misalignments in theprefilled syringe are also rendered operationally less significant dueto the gentle insertion of the needle that is possible with thisconfiguration.

Preferably, the injecting position of the guard 66 is such that apredetermined length of the end of needle 24 is exposed from the guard66. In some embodiments, such as where the opening 74 is of asufficiently large diameter, the skin of the patient maybe allowed toextend into the opening 74 when the device 10 is pressed there against,and a needle that does not protrude beyond the distal end of the guard66 can be used while still penetrating the skin to a certain depth. Inmost embodiments, the distance 76 by which the needle tip 26 extendspast the distal end of the guard 66 will be fairly close to the depth ofthe insertion of the needle.

In the preferred embodiment, such as for subcutaneous injection, theguard 66 is configured to allow insertion of the needle to a penetrationdepth in the skin that is up to about 5 mm below the skin surface. Morepreferably, the penetration depth is less than about 4 mm, and in oneembodiment is less than about 3 mm. Preferably, the insertion depth isat least about 0.5 mm and more preferably at least about 1 mm. Inanother embodiment, the distance 76 by which the needle extends past theguard 66 or the distal surface of the guard 66 that contacts the skin isup to about 5 mm, more preferably up to about 4 mm, and in oneembodiment up to about 3 mm. Preferably, extension distance 76 is atleast about 0.5 mm, more preferably at least about 1 mm, and mostpreferably at least about 2 mm. In a preferred embodiment, tip 26extends by a distance 76 of around 2.5 mm beyond the portion of theguard 66 that contacts the skin in the injecting position.

In another embodiment, such as for intramuscular injection, the injectoris configured to allow the needle to be inserted into the patient to apenetration depth in the skin, or alternatively beyond the distalsurface of the guard, by a distance of up to about 15 mm. In oneembodiment, this distance is about between 10 mm and 14 mm. In anembodiment for jet injection of epinephrine for instance, a preferredpenetration depth or distance beyond the guard is between about 12 mmand 13.5 mm, and most preferably around 12.7 mm. Jet injection with thislength needle improves the distribution of the medicament in the patienttissue compared to non jet injection. Other exposed needle lengths canbe selected for jet injection to different depths below the skin, with apreferred overall penetration length of between about 0.5 mm and about20 mm. In these embodiments, the needle guard is preferably configuredfor retracting from a protecting position, preferably covering theentire needle, to an injecting position, in which the desired length ofthe end of the needle is exposed.

The spring 62 and the prefilled syringe 18 are configured to jet injectthe medicament. Thus, the spring 62 applies a force on the plunger 28that is sufficient to elevate the pressure within the fluid chamber 22to a level high enough to eject the medicament from the needle 24 as ajet. Jet injection is to be understood as an injection with sufficientvelocity and force to drive the medicament to locations remote from theneedle tip 26. In manual and autoinjector-type injections, in which theinjection pressures are very low, the medicament exits the needle tipinside the patient and is typically deposited locally around the needlein a bolus. On the other hand, with the present jet injection device 10,the medicament is jet injected distally or in other directions, such asgenerally radially by the elevated pressure jet, which beneficiallyimproves the distribution of the medicament after the injection andkeeps a large bolus from forming that can detrimentally force themedicament to leak back out of the patient around the needle or throughthe hole left behind by the needle after it is removed.

Referring to the graph shown in FIG. 6, numeral 78 represents the pointin time when device 10 is fired, and numeral 80 represents the point ofcompletion of the medicament injection, preferably when the plunger 28hits the forward wall of the container portion 20. Numeral 82 representsthe initial and peak pressure during the injection, and numeral 84represents the final and low pressure during the injection. Since thespring 62 of the preferred embodiment has a linear spring constant andan injection-assisting needle is used to puncture the skin beforecommencing the injection, the pressure drops substantially linearly fromthe start of the injection 78 until the injection is completed. Thefinal pressure 84 at the end 80 of the injection is sufficientlyelevated so that even at the end of the firing stroke of ram 60, themedicament is still jet injected, and a very small amount or none of themedicament is deposited in a bolus around the needle tip 26.

Preferably the peak pressure during the injection is less than about1,000 p.s.i., more preferably less than 500 p.s.i., and most preferablyless than about 350 p.s.i. At the end 80 of the injection, the pressure84 applied to the medicament in the fluid chamber 22 is preferably atleast about 80 p.s.i., more preferably at least about 90 p.s.i., andmost preferably at least about 100 p.s.i. In one embodiment of theinvention, the initial pressure 82 is around 330 p.s.i., and the finalpressure is about 180 p.s.i., while in another embodiment the initialpressure 82 is about 300 p.s.i., dropping to around 110 p.s.i. at theend 80 of the injection. The needles used in these embodiments arebetween 26 and 28 gage, and are most preferably around 27 gage, butalternatively other needle gages can be used where the other componentsare cooperatively configured to produce the desired injection.Preferably, the components of the injector 10 are configured to jetinject the medicament to a subterraneous injection site.

The amount of medicament contained and injected from fluid chamber 22 ispreferably between about 0.02 mL and 4 mL, and preferably less thanabout 3 mL, and in the preferred embodiment is around 1 mL. Largervolumes may also be selected depending on the particular medicament anddosage required. Preferably, the prefilled syringe is assembled into theremaining parts of the jet injector 10 already containing the desiredamount of medicament. In a preferred embodiment, the prefilled syringecontains about 1 mL of medicament.

Preferred injection rates are below about 0.75 mL/sec., more preferablybelow about 0.6 mL/sec., and preferably at least about 0.2 mL/sec., morepreferably at least about 0.3 mL/sec, and most preferably at least about0.4 mL/sec. Preferably, the injection of the entire amount of medicamentis completed in less than about 4 seconds, more preferably in less thanabout 3 seconds, and most preferably in less than about 2.5 seconds.Preferably, the medicament injection takes at least about 1 second, andmore preferably at least 1.5 seconds, and most preferably at least about1.75 seconds. A preferred embodiment injects the medicament at about 0.5mL/sec., completing the injection of 1 mL in about 2 seconds.

U.S. Pat. No. 6,391,003 discloses several experimental results ofpressures that can be applied to medicament in a glass cartridge, using26 and 27 gage needles. The following table illustrates injections withdifferent peak pressures that can be used with glass prefilled syringes:

Pressure and Time (sec.) to Inject 1 cc Pressure 26 Gauge needle 27Gauge needle 150 p.s.i. 2.1 4.2 200 p.s.i. 1.9 3.9 240 p.s.i. 1.7 3.3375 p.s.i. 1.4 3.1

It is foreseen that higher pressures and flow rates will be used withshorter needle penetration into the patient skin to achieve jetinjections to a particular desired depth substantially withoutmedicament leakback.

It has been found that using the jet injection of the present device,short needles can be used to inject medicament to different parts of theskin, preferably subcutaneously, substantially without any leakback.Using a needle that extends by about 2.5 mm from the needle guard 66, a27 gauge needle 24, and a pressure in the fluid chamber 22 peaking ataround 300 p.s.i. and ending at around 100 p.s.i., resulting in a flowrate of about 0.5 mL/sec., 1 mL of medicament has been found tosuccessfully be injected without leakback in close to 100% of the testedinjections. Thus, the needle-assisted jet injector of the presentinvention permits jet injection of the medicament using a very shortneedle reliably regardless of the thickness of the patient's skin or thepatient's age, weight or other typical factors that complicate non-jetinjecting with short needles.

FIGS. 7 and 8 show another embodiment of the present invention that usesa prefilled syringe that has a long, but smaller-diameter configurationthan the embodiment of FIG. 2. While in the embodiment of FIG. 2, thefiring spring 62 extends into the bore of the prefilled syringe 18during the firing stroke, the narrower prefilled syringe 88 of injector86 does not provide as much space to accommodate a spring. Consequently,the ram 90 of injector 86 includes a bell portion 92 defining a hollowinterior 94 that is configured to receive the proximal end of theprefilled syringe 88 and the syringe support 96 when the injector 86 isfired. Similarly, a bell-receiving space 98 is defined around theexterior of the prefilled syringe 88 and syringe support 96 to receivethe bell portion 92 during the firing. The bell 92 includes a springseat 100 extending radially outwardly and configured and disposed toseat a compression spring 102. When the trigger mechanism 56 isactivated and the device 86 is fired, spring 102 acts against seat 100to drive the ram 90 against plunger 104 to jet inject the medicamentfrom the fluid chamber 106. As a result, after firing, the spring 102radially surrounds the prefilled syringe 88. The outer housing portion108 is wider than outer housing portion 14 of injector 10 to accommodatethe bell portion 92 and larger diameter spring 102.

One available long configuration syringe with a 1 mL capacity has acylindrical syringe body portion with a diameter of 8.15 mm, which wouldtypically be used in the injector of FIGS. 7 and 8, while one availableshorter configuration syringe of the same capacity has a cylindricalsyringe body portion with a diameter of 10.85 mm, which would be used inthe injector of FIGS. 1 and 2. While the embodiment with a bell portioncan be used with wider/shorter syringes, I is preferred with prefilledsyringes having an outer diameter cylindrical wall of less than about 10mm, and more preferably of less than about 9 mm.

Injector 86 also includes a cap 110 fitted around the needle guard 66,and associated with the outer housing 108 to prevent retraction of theneedle guard 66 and the triggering of the device 86. Additionally, thecap 110 seals off the needle tip 26 and can be removed prior to usingthe device 86. The cap 110 is preferably configured to fit over theneedle guard 66 in a snap-fit association therewith, such as byincluding a narrower diameter portion 112 associated with an enlargeddiameter portion 114 of the needle guard 66.

Additionally, injector 86 employs a syringe cushion cap 116 that extendsaround the outside of the syringe flange 34 from the syringe cushion 118to help trap and retain the prefilled syringe 88. A cushion cap 122 isconnected to the cushion 118 and is preferably of unitary constructiontherewith. The cushion cap 122 abuts the distal end of the syringe body120 to radially position and hold the proximal end of the body 120 whilethe needle 24 is being inserted into the patient. Similarly to theembodiment of FIG. 2, the syringe holder 96 is associated with thehousing in a substantially fixed position, such as by mounting portion124, which traps protrusions 126 of the syringe holder.

Referring to FIG. 9, injector 128 has a needle guard 130 configured toretract further into the injector housing than the injector of FIGS. 1and 2 or FIG. 5 before the trigger mechanism 52 fires the jet injection.The injector in this figure is shown in a position in which the triggermechanism 52 is being released and about to fire the injection. Thedistance 76 by which the needle extends past the guard 130 or the distalsurface of the guard 130 that contacts the skin preferably between about12.5 and 13 mm. In the preferred embodiments, the guard is preferablyconfigured to reextend to a protecting position after the device isfired and removed from the patient, such as under the bias of spring 72,and is locked in that position by locking members 132, as known in theart to prevent reuse on the injector.

In other embodiments, the guard length, the location of the guardinjecting position with respect to the needle tip (including the guardthrow between the protecting and injecting positions), and the length ofthe needle from the syringe body can be selected to allow for shalloweror deeper needle insertions before the device is fired, providing lesseror greater distances 76, respectively. Preferably, the guard is keptfrom sliding further back than substantially at the firing position, tobetter control in insertion depth into the patient.

The entire disclosure of U.S. Pat. No. 6,391,003 is hereby incorporatedherein by reference thereto.

While illustrative embodiments of the invention are disclosed herein, itwill be appreciated that numerous modifications and other embodimentsmay be devised by those skilled in the art. For example, the featuresfor the various embodiments can be used in other embodiments, such asthe needle and guard cap of FIGS. 7 and 8, which can be applied to theembodiment of FIG. 1. Therefore, it will be understood that the appendedclaims are intended to cover all such modifications and embodiments thatcome within the spirit and scope of the present invention.

What is claimed is:
 1. A jet injector, comprising: a prefilled syringe comprising: a container portion defining a fluid chamber containing a medicament, an injection-assisting needle disposed at a distal end of the fluid chamber, the injection-assisting needle having an injection tip configured for piercing an insertion location, and defining a fluid pathway in fluid communication with the fluid chamber for injecting the medicament from the fluid chamber into an injection site, wherein the injection-assisting needle is adhered to the container portion, a syringe body that includes a flange and a wall and hub of unitary construction, and a plunger movable within the fluid chamber; a housing that houses the prefilled syringe and is configured for allowing insertion of the injection-assisting needle at the injection location to an insertion point that is at a penetration depth below a surface at the insertion location, wherein the housing comprises a retractable guard that is movable between: a protecting position in which the injection-assisting needle is disposed within the guard; and an injecting position in which the tip of the injection-assisting needle is exposed for insertion to the insertion point; a syringe support supportively mounting the prefilled syringe to the housing; a syringe cushion associated with the syringe support and prefilled syringe and made of an elastomeric material to compensate for shape irregularities of the pre-filled syringe; an energy source configured for biasing the plunger with a force selected to produce an injecting pressure in the medicament in the fluid chamber that substantially remains below 500 p.s.i. during the injection of the medicament to jet inject the medicament from the fluid chamber through the injection-assisting needle to the injection site; and a trigger mechanism operably associated with the energy source for activating the energy source to jet inject the medicament, wherein the trigger mechanism is configured for activating the energy source after the retractable guard is retracted from the protecting position, wherein the penetration depth and injecting pressure are sufficient to substantially prevent backflow of the injected medicament.
 2. The jet injector of claim 1, wherein the energy source and prefilled syringe are configured such that the injecting pressure remains up to about 350 p.s.i. during the injection of the medicament.
 3. The jet injector of claim 2, wherein the energy source is configured to produce the injecting pressure that remains at least at about 90 p.s.i. during the injection of the medicament.
 4. The jet injector of claim 1, wherein the penetration depth is between about 0.5 mm and 5 mm below the surface at the insertion location.
 5. The jet injector of claim 1, wherein the housing is configured for allowing insertion of the needle to subcutaneous depth.
 6. The jet injector of claim 1, wherein the energy source comprises a spring.
 7. The jet injector of claim 6, further comprising a ram that is biased by the spring against the plunger to produce the injection pressure, wherein the ram comprises a bell portion on which the spring is seated, and the bell portion defines a hollow interior configured for receiving the prefilled syringe when the jet injector is fired, such that the spring surrounds the prefilled syringe.
 8. The jet injector of claim 1, wherein: the prefilled syringe has a distal portion in which the injection-assisting needle is located, and a proximal portion opposite the distal portion; and the syringe support axially supports the proximal portion of the pre-filled syringe during the jet injection of the medicament, such that the distal portion of the prefilled syringe is substantially unsupported in an axially direction.
 9. The jet injector of claim 1, wherein the fluid chamber contains about between 0.02 mL and 4 mL of the medicament.
 10. The jet injector of claim 1, wherein the retractable guard is operably associated with the trigger mechanism to cause the trigger mechanism to activate the energy source when the retractable guard is retracted to the injecting position.
 11. The jet injector of claim 1, wherein the prefilled syringe is associated with the housing in a fixed position before and during activation of the energy source for firing of the jet injector.
 12. The jet injector of claim 1, wherein the syringe cushion comprises a resilient sleeve portion configured to provide shock absorption during firing of the jet injector.
 13. The jet injector of claim 1, wherein the syringe cushion supports the flange. 